§ 252. Procedures for determinations relating to package, or form of
dosage or administration, of certain drugs. 1. If the department of
health makes an initial determination that a particular package, or form
of dosage or administration, of a drug shall be excluded in accordance
with the provisions of paragraph (b) of subdivision one of section two
hundred forty-one of this title, the executive department shall notify
the manufacturer of such drug product that the executive department
intends to seek the exclusion of such package, or form of dosage or
administration, from the program and shall provide such manufacturer
with the reasons therefor together with the facts which the department
relies upon to support its initial determination. The manufacturer shall
have fifteen days after receiving such exclusion notice to notify the
executive department of an intent to appeal the decision. If the
manufacturer fails to notify the executive department of an intent to
appeal within the time specified in this section, the commissioner of
health shall forthwith determine whether the package, or form of dosage
or administration, shall be excluded from the program. If the
manufacturer notifies the executive department of an intent to appeal,
the manufacturer shall submit to the executive department within
forty-five days of receiving such exclusion notice, the basis of the
manufacturer's appeal. Within fifteen days of receiving such submission
from the manufacturer, the executive department shall provide to the
manufacturer any additional facts concerning the drug product that the
department relies upon to support its initial determination. Within ten
days of receiving such facts, the manufacturer may submit additional
facts concerning the drug package, or form of dosage or administration.
Based on the facts submitted pursuant to this section, the commissioner
of health shall make a final determination, in accordance with the
standard set forth in paragraph (b) of subdivision one of section two
hundred forty-one of this title, as to whether the package, or form of
dosage or administration, of the drug product shall constitute a covered
drug for the purposes of this article. A determination to exclude the
drug package, or form of dosage or administration, shall be subject to
judicial review pursuant to article seventy-eight of the civil practice
law and rules.

2. The commissioner of health shall establish by regulation an
appropriate process allowing drug packages, or forms of dosage or
administration, finally determined under this section not to be covered
drugs for the purposes of this title to be dispensed to program
participants for whom such drug packages, or forms of dosage or
administration, are medically indicated as certified to by a physician
treating such participant. Any such drug package, or form of dosage or
administration, so certified as medically indicated for a specific
participant in accordance with such regulations shall be a covered drug
for the purpose of this title.